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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01635166
Other study ID # CT11/01
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 1, 2012
Est. completion date February 8, 2018

Study information

Verified date July 2018
Source DePuy International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Recruitment information / eligibility

Status Terminated
Enrollment 250
Est. completion date February 8, 2018
Est. primary completion date February 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.

v) Subjects who are currently involved in any injury litigation claims.

Study Design


Intervention

Device:
Delta Motion
A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.

Locations

Country Name City State
India Apollo Speciality hospital, 320 Anna Salai Chennai
India All India Institute of Medical Sciences, Ansari nagar, South Extension New Dehli
United Kingdom Robert Jones and Agnes Hunt Oswestry

Sponsors (1)

Lead Sponsor Collaborator
DePuy International

Countries where clinical trial is conducted

India,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kaplan-Meier survivorship To determine survivorship of the DeltaMotion Cup System at 3 years 3 years
Secondary Kaplan-Meier survivorship To determine survivorship of the DeltaMotion Cup System at 10 years 10yrs post-surgery
Secondary Harris Hip Score Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion. 10yrs post-surgery
Secondary Oxford Hip Score Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery. 10yrs post-surgery
Secondary University of California Los Angeles (UCLA) Score Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement 10yrs post-surgery
Secondary Western Ontario and McMaster Universities (WOMAC) Score Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee 10yrs post-surgery
Secondary Radiological analysis Acetabular Migration (vertical or horizontal) less than 5mm
Acetabular Migration (varus or valgus) less than 5 degrees
No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones.
10yrs post-surgery
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